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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00154128
Other study ID # RD-B-01
Secondary ID
Status Completed
Phase Phase 1
First received September 8, 2005
Last updated November 17, 2005
Start date April 2005
Est. completion date August 2005

Study information

Verified date September 2005
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The study was designed to investigate a possible influence of an occlusal stabilization splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal splints are therapeutic devices that are most frequently used in the treatment of TMD. Changes of the mandibular position and occlusal equilibrations are assumed to have an impact on the general body posture.


Description:

Thirty TMD cases and 10 controls were included in the study. All participants were recruited from the School of Dentistry, University of Greifswald. All subjects gave their written consent to participate in the study. They then completed a TMD history questionnaire and underwent a clinical examination. The examination included palpation of the masticatory muscles and the TMJs, range of mandibular motion measurements, and assessment of joint noises. The TMD cases were required to have a diagnoses of myofascial pain and/or arthralgia. Controls had to be free of pain symptoms in their masticatory muscles and TMJs. Body posture was measured during five minutes of walking using an ultrasound-distance measuring device (sonoSens® Monitor) with small sensors placed on the skin that continually record changes in the distance between them. A static posture evaluation was performed with a contactless, and radiation-free static measurement of the back surface and spine using a 3D measurement system (formetric II). A second measurement was performed after insertion of the occlusal appliance and a third one after 7 days of treatment.

The occlusal appliances were inserted after the first examination and all participants were instructed to use it at night and during examinations.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- TMD cases: diagnoses of myofascial pain and/or arthralgia

Exclusion Criteria:

- TMD cases: chronic systemic diseases, cardiac pacemakers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
occlusal appliance


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medicine Greifswald

Outcome

Type Measure Description Time frame Safety issue
Primary changes in body posture
Secondary score of compliants
Secondary number of tender muscles and TMJs
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